ICU Medical CL-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00887709056961), received between Oct 3, 2017 and Jun 11, 2025 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (8 reports).

1 FDA recall record name this device's identifier, 1 still open.

59 other recalls cover devices cleared under the same FDA submission (K131549); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Sep 8, 2025Class IIOpen, Classified

   Port weld of drug transfer device may separate or break during use and potentially result in a leak.

   Z-0341-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 11, 2025Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A CHEMOLOCK¿ BAG SPIKE WHERE IT WAS REPORTED THE PRODUCT WAS BROKEN WHICH RESULTED IN LEAKAGE. THERE WAS UNKNOWN PATIENT INVOLVEMENT, UNKNOWN HUMAN HARM AND UNKNOWN DELAY IN THERAPY. THIS REPORT CAPTURES 2 SAME/SIMILAR OCCURRENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22185109 ↗
• MalfunctionJun 11, 2025Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  THE CHEMOLOCK PORTION OF THE DEVICE WAS BROKEN AND THIS IS WHAT CAUSED THE LEAKAGE PER THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22185074 ↗
• MalfunctionApr 25, 2025Break; Break

  A COMPLAINT WAS RECEIVED REGARDING A CHEMOLOCK¿ BAG SPIKE THAT EXPERIENCED BREAKAGE DURING USE. THE REPORTER STATED THAT THE PRODUCT WAS BROKEN. THE EVENT DATE OCCURRED ON 10-APR-2025. STATUS WAS DURING IN USE FOR PATIENT. THE MEDICATION USED WHEN THIS EVENT OCCURRED WERE CYCLOPHOSPHAMIDE 500MG/250ML NORMAL SALINE. THUS, THERE WAS PATIENT INVOLVEMENT, UNKNOWN HUMAN HARM AND UNKNOWN DELAY IN THERAPY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21909767 ↗
• MalfunctionApr 25, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A COMPLAINT WAS RECEIVED REGARDING A CHEMOLOCK¿ BAG SPIKE THAT EXPERIENCED BREAKAGE DURING USE. THE MEDICATION SPILLED ONTO THE FLOOR. IT WAS ALSO STATED THAT ROUGHLY 30ML SPILLED ONTO THE FLOOR. ONCE THE IV CHEMO WAS PUT BACK INTO A PLASTIC BAG, MOST OF THE MEDICATION SPILLED INTO THE BAG. A SPILL KIT WAS USED AND CYCLOPHOSPHAMIDE WAS THE MEDICATION IN THE BAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21909746 ↗
• MalfunctionFeb 13, 2025Particulates; Particulates

  IT WAS REPORTED THAT, ON AN UNSPECIFIED DATE, A CHEMOLOCK¿ BAG SPIKE WAS FOUND TO CREATE PARTICULATE MATTER DURING PATIENT USE. IT WAS REPORTED THAT THE BAGS (96) WERE CREATING PARTICULATE WHEN PUNCTURED WITH THE CLOSED SYSTEM TRANSFER DEVICE (CSTD) BAG SPIKE. IT WAS NOTED THAT THEY USED A 500 ML FRESENIUS KABI 0.9% SODIUM CHLORIDE INJECTION, NON-DEHP BAGS. THE EVENT OCCURRED DURING COMPOUNDING INSIDE THE BSC. THERE WAS NO PATIENT INVOLVEMENT, AND NO HUMAN HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21381402 ↗
• MalfunctionFeb 13, 2025Particulates; Particulates

  THE EVENT INVOLVED A CHEMOLOCK¿ BAG SPIKE WHERE IT WAS NOTED THAT BLUE PARTICULATE CAN BE SEEN ON THE SPIKE. IT WAS NOTED THAT THEY USED A 500 ML FRESENIUS KABI 0.9% SODIUM CHLORIDE INJECTION, NON-DEHP BAGS. THE EVENT WAS NOTED DURING COMPOUNDING INSIDE THE BSC. THERE WAS NO PATIENT INVOLVEMENT, AND NO HUMAN HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21379774 ↗
• MalfunctionFeb 13, 2025Particulates; Particulates

  THE EVENT INVOLVED A CHEMOLOCK¿ BAG SPIKE WHERE IT WAS NOTED THAT BLUE PARTICULATE CAN BE SEEN ON THE SPIKE. IT WAS NOTED THAT THEY USED A 1000 ML FRESENIUS KABI 0.9% SODIUM CHLORIDE INJECTION, NON-DEHP BAGS. THE EVENT WAS NOTED DURING COMPOUNDING INSIDE THE BSC. THERE WAS NO PATIENT INVOLVEMENT, AND NO HUMAN HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21379388 ↗
• MalfunctionFeb 13, 2025Particulates; Particulates

  IT WAS REPORTED THAT A CHEMOLOCK¿ BAG SPIKE WAS FOUND TO CREATE PARTICULATE MATTER IN THE FLUID PATH OF THE PATIENT DURING COMPOUNDING. IT WAS NOTED THAT BLUE PARTICULATE CAN BE SEEN ON THE SPIKE. IT WAS NOTED THAT THEY USED A 250 ML FRESENIUS KABI 0.9% SODIUM CHLORIDE INJECTION, NON-DEHP BAG. A SAMPLE PICTURE WAS PROVIDED SHOWING THE PARTICULATE ON THE SPIKE. THERE WAS NO PATIENT INVOLVEMENT AND NO HUMAN HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21377176 ↗
• MalfunctionFeb 13, 2025Particulates; Particulates

  IT WAS REPORTED THAT, ON AN UNSPECIFIED DATE, A CHEMOLOCK¿ BAG SPIKE WAS FOUND TO CAUSE PARTICULATE IN THE FLUID PATH DURING COMPOUNDING. IT WAS REPORTED THAT THE BAGS WERE CREATING PARTICULATE WHEN PUNCTURED WITH THE CLOSED SYSTEM TRANSFER DEVICE (CSTD) BAG SPIKE. IT WAS NOTED THAT THEY USED 9 X 1000 ML FRESENIUS KABI 0.9% SODIUM CHLORIDE INJECTION, NON-DEHP BAGS. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21376558 ↗
• MalfunctionAug 27, 2024Material Puncture/Hole; Material Puncture/Hole

  THE EVENT INVOLVED A CHEMOLOCK¿ BAG SPIKE. THE REPORTER STATED THAT THE TIP OF THE SPIKE IS TOO SHARP, AND NOT BEVELED SO IT PUNCTURES THE SIDE OF THE IV BAG, ALSO, THE SPIKE IS TOO LONG SO ANOTHER REASON WHY THE SPIKE PUNCTURES THE BAG. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20077603 ↗
• MalfunctionAug 15, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A CHEMOLOCK¿ BAG SPIKE WHERE IT WAS REPORTED THAT THE REPORT THAT SPIKE PUNCTURED THROUGH IV CHEMOTHERAPY AND CAUSED A CHEMO SPILL AND DRIPPED ONTO SKIN CAUSING CYTOTOXIC EXPOSURE TO NURSE. THERE WAS PATIENT INVOLVEMENT BUT NO DELAY IN THERAPY.

  Patient problems: Chemical Exposure; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19997496 ↗
• MalfunctionJun 17, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A CHEMOLOCK¿ BAG SPIKE WHERE THE CUSTOMER REPORTED THAT THE SPIKE PUNCTURED THROUGH IV CHEMOTHERAPY AND CAUSED A CHEMO SPILL AND DRIPPED ONTO SKIN CAUSING CYTOTOXIC EXPOSURE TO NURSE. THERE WAS A PATIENT INVOLVED BUT NO NO ADVERSE OUTCOME WAS REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: Chemical Exposure; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19554911 ↗
• MalfunctionApr 4, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING USE WITH A CHEMOLOCK¿ BAG SPIKE A CISPLATIN BAG LEAK OCCURRED DUE TO THE SPIKE POKING A HOLE THROUGH A BAXTER PORT RESULTING IN THE CHEMOTHERAPY COMING IN CONTACT WITH THE PATIENT OR HEALTHCARE PROVIDER. THE DRUG WAS REMIXED AND CHEMOLOCK WAS NOT REPLACED. THERE WAS PATIENT INVOLVEMENT BUT NO HARM WAS REPORTED. THIS IS REPORT 2 OF 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13994969 ↗
• MalfunctionApr 4, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING USE WITH A CHEMOLOCK¿ BAG SPIKE A CISPLATIN BAG LEAK OCCURRED DUE TO THE SPIKE POKING A HOLE THROUGH A BAXTER PORT RESULTING IN THE CHEMOTHERAPY COMING IN CONTACT WITH THE PATIENT OR HEALTHCARE PROVIDER. THE DRUG WAS REMIXED AND CHEMOLOCK WAS NOT REPLACED. THERE WAS PATIENT INVOLVEMENT BUT NO HARM WAS REPORTED. THIS IS REPORT 1 OF 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13994961 ↗
• MalfunctionMar 24, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A CHEMOLOCK¿ BAG SPIKE WHICH WAS REPORTED TO HAVE AN IRINOTECAN BAG POKING THROUGH A BAXTER PORT RESULTING IN A LEAK. THE EVENT HAPPENED WHEN THE NURSE WAS READY FOR ADMINISTRATION, IT CAME INTO CONTACT WITH THE NURSE, AND THE SPILL WAS CLEANED UP. THE DRUG WAS REMIXED USING CHEMOLOCK COMPONENTS AND A NEW BAG OF MEDICATION WAS REPLACED. THERE WAS A HOLE IN THE PORT. THERE WAS PATIENT INVOLVEMENT, BUT NO HARM REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: Chemical Exposure; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13893142 ↗
• MalfunctionOct 3, 2017Connection Problem; Connection Problem

  CL-10 CHEMOLOCK BAG SPIKE, LOT UNKNOWN WAS REPORTED THAT ONCE PREPARATION WAS COMPLETE AND SENT TO THE NURSING STAFF, NURSE TRIED TO CONNECT TUBING DEVICE. AT THAT POINT THE BLUE TIP DISLODGED FROM THE ADAPTOR PORTION. THIS CREATED AN OPEN SYSTEM HAVING HAZARDOUS MEDICATION LEAK OUT OF THE IV BAG. NO PATIENT INVOLVEMENT WAS REPORTED. INFORMATION FROM THE CUSTOMER REVEALS THAT THE LEAKING OCCURRED IN THE PHARMACY. NO PRODUCT WAS RETURNED, THEREFORE TESTING OF THE DEVICE COULD NOT OCCUR. A TWO-YEAR REVIEW OF THE COMPLAINTS DATABASE REVEALED NO OTHER INCIDENTS FOR THIS LIST #/SIMILAR PROBLEM.

  Patient problems: Chemical Exposure

  MAUDE report 6911059 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K131549. One submission often covers many models, so check the product and lot details in each record.

• Z-3159-2026 · May 12, 2026 · Open, Classified
  Oncology sets with drip chambers
• Z-3161-2026 · May 12, 2026 · Open, Classified
  IV Sets with drip chambers
• Z-2210-2026 · Mar 24, 2026 · Open, Classified
  Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros; ChemoLock; Syringe Transfer Set w/MicroClave, ChemoLock Port, REF: CL
• Z-0343-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Universal Vented Vial Spike REF: CL-70
• Z-0342-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical Double ChemoLock Port Syringe Transfer Set REF: CL-33
• Z-0334-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical Oncology Kit w/31" (79 cm) 20 Drop Admin Set w/Integrated ChemoLock" Port Drip Chamber, Spiros"; ChemoLock"; ChemoLock" Universal Vented Vial Spike; Bag Hanger REF: C
• Z-0355-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock w/Mini Bag Spike REF: C-17
• Z-0356-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical Syringe Transfer Set w/MicroClave, ChemoLock Port REF: CL-34
• Z-0361-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical 6" (15 cm) Ext Set w/MicroClave" Clear, ChemoLock" Port, Y-Connector, Rotating Luer REF: CL4118
• Z-0330-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock" Port, Bulk, Non-Sterile REF: CL2100-NS
• Z-0359-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical 31" (79 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Purple Cap, Hanger REF: CL3951
• Z-0345-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Vented Vial Spike, 13mm REF: CL-72
• Z-0335-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical ChemoLock Bag Spike with Clave Additive Port REF: CL3940
• Z-0337-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical Oncology Transfer Kit w/ChemoClave and ChemoLock Port; Spiros w/Red Cap; ChemoLock Port REF: CL4138
• Z-0362-2026 · Sep 8, 2025 · Open, Classified
  ICU Medical Oncology Kit w/2 ChemoLock", 13mm Closed Vial Spike w/ChemoLock" Port, ChemoLock" Bag Spike, Ext Set w/ChemoLock" Port, Clamp, Graduated Adapter REF: CL4188

…and 44 more.